Vaccine manufacturer Bharat Biotech is working on an intra-nasal vaccine against Kovid-19, called Kovoflu, in collaboration with the US-based vaccine company Flujon and the virologist University of Wisconsin (UW) -Madison. The company will manufacture the vaccine, conduct clinical trials and produce approximately 300 million doses for global distribution.
Under the agreement, Fluonne will transfer its existing manufacturing processes to Bharat Biotech, to help the company produce the vaccine for clinical trials, and later, to scale up production, head of business development Dr. Said Rax Ella, Bharat Biotech.
Ella said, “Bharat Biotech has commercialized 16 vaccines, including one developed against H1N1 flu, including the 2009 pandemic.” Coroflu will be formed on the backbone of Fluagen’s flu vaccine candidate called M2SR.
Based on an invention by UW-Madison virologist and Flujan co-founders Yoshihiro Kawaoka and Gabriel Newman, M2SR is a self-limiting version of the influenza virus that induces an immune response against the flu. Kavoca’s lab will insert gene sequences from SARS-CoV-2 into the novel coronavirus, M2SR, which causes Covid-19, so that the new vaccine will also induce immunity against the virus.
It is expected to take three to six months to refine the concept of the Coroflu vaccine and test it on animals in the UW-Madison laboratory. Bharat Biotech will then scale up production for human safety and efficacy-testing. Coroflu may be ready for clinical trials on humans by the fall of 2020. Mucosal immunity in the lining of the nose and respiratory tract is very important for respiratory disease. Coroflu is based on the influenza vaccine and will provide immunity to H2N2 strains of seasonal influenza.
Four phase I and phase II clinical trials, involving hundreds of subjects, have shown the M2SR flu vaccine to be safe and well tolerated. This safety profile, a rapid immune response of M2SR and the ability of influenza viruses to carry sequences of other viruses to rapidly evolve M2SR as a safe and effective SARS-CoV-2 vaccine Makes attractive choices.
“We are going to modify M2SR by adding part of the coding region for coronovirus spike proteins that it uses to latch onto virus cells and initiate infection,” a senior virologist at Kawakoka’s lab and co-founder of Flujon Said Gabriel Newman. “Coroflu influenza virus will also express hemagglutinin protein, which is the predominant influenza virus antigen, so we should have an immune response to both coronoviruses and influenza.”
M2SR is a unique form of the flu virus. It lacks a gene called M2, which prevents the virus from replicating only one round in the cells. “Single replication means that the virus can enter the cell, but it cannot,” said Paul Redspiner, Flujan co-founder, president and CEO. “So, in a nutshell it turns the body into thinking flu-infected, which triggers a complete immune response. But since it won’t replicate further, you won’t get sick.”
CoroFlu, like M2SR, will be given intra-nasal. This route of administration mimics the natural route of infection by coronaviruses and influenza and activates several modes of the immune system. Intra-nasal delivery is more effective in inducing multiple types of immune responses than intramuscular shots that deliver most flu vaccines. The Kawaoka group will insert a genetic sequence from SARS-CoV-2 into M2SR and then assess the safety and efficacy of CoroFlu in animals at the Influenza Research Institute of UW-Madison.
The institute has a high-level biosafety facility that specifies biosafety level 3 agriculture with the ability to safely handle and study pathogens such as highly pathogenic influenza viruses and novel coronaviruses. The M2SR was developed by Fluen and includes technology exclusively licensed through the Wisconsin Alumni Research Foundation (WARF), which manages patents for UW-Madison.